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October 1999

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Subject:
From:
Michael C Carroll <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 4 Oct 1999 22:18:01 -0400
Content-Type:
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        Simplest answer: STRICT.
        Much will depend on your OWN definition of a "production batch"-- but
I've never heard of anyone getting away with lumping multiple production
lots into a single sterilizer load and calling the whole thing a "lot".
And rarely does even a constant "commodity", like purified water or WFI,
get treated as anything broader than one "lot" per day.
        As to sterilizing the finished product before or after testing for
LAL:You could argue that one both ways. One way, a product which has not
yet been sterilized is not in fact a "finished product". The other way,
if the product does not contain endotoxins BEFORE sterilization, there
should be no reason to suppose it will suddenly contain them AFTER.
        Best way might be to pick a sound, well-defined position, backed by
good, defensible science, and ASK them if they agree or disagree.
        M. Carroll
        [log in to unmask]
On Mon, 4 Oct 1999 15:28:24 -0500 Barbara Spears
<[log in to unmask]> writes:
> Greetings!
>
> I have a question regarding the term "lot" as stated in the FDA LAL
> guideline.
> When "pyrogen-free" is stated on the label claim for medical
> devices. Each lot
> must be tested. Is this a strict or loose interpretation of the term
> "lot"? Does
> this mean each production lot must be tested? Or can  "lot" be
> interpreted as a
> "sterilization load" (consisting of more than one production lot),
> or can "lot"
> be further broadened  to mean the number of products (regardless of
> the number
> of production lot numbers and product configurations) that are
> produced in a
> specified increment of time (i.e. all products produced in a day or
> week)?
>
> Is it mandatory that product be sterilized prior to conducting the
> LAL finished
> product test?
>
> Thank you in advance for your responses.
> Barbara
>
>
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